Medical puncturing device

ABSTRACT

The invention relates to a medical puncturing device comprising a rigid needle being at one end adapted for facilitating the puncturing and comprising at the opposite end a hub, the hub comprising a handle part and a shield part being pivotable in relation to the handle part and further comprising locking means on the shield part and the handle part, the locking means being adapted to interlock the shield and the handle part in a pivoted position of the shield part where the rigid needle is covered by this.

BACKGROUND OF THE INVENTION

The present invention relates to a medical puncturing device e.g. for use in connection with the insertion of a soft cannula where the soft cannula e.g. forms part of a infusion device for subcutaneous delivery of a medication or a therapeutic fluid by means of an external infusion system and more particularly to a medical puncturing device capable of being discarded without the danger of causing unintended harmful injuries to persons afterwards.

The medical puncturing device will in the following be explained in connection with the field of subcutaneous infusion devices. Such infusion devices are generally known in the art for delivering a medication or a therapeutic fluid to a subcutaneous site in a patient. Such devices commonly comprise a soft tubular cannula extending from a housing adapted to receive the desired medication via means, e.g. disconnectable means, for suitable connection to further components of the infusion system. The possibility of disconnecting the infusion set from the further parts of the infusion system is provided in order to improve the user comfort. In order to place the soft cannula at a subcutaneous delivery site, a medical puncturing device comprising a rigid needle and a handle is used. The rigid needle is inserted through the hollow soft cannula and extends beyond the outer tip of this. The soft cannula is inserted into the subcutaneous fat layer of the patient together with the rigid needle, which is afterwards withdrawn leaving the soft cannula at the infusion site. In order to provide such disconnectable medical puncturing device and still maintain a fluid-tight sealing towards the interior of the housing and the tubular cannula that prevents contamination of the infusion site, such devices are commonly provided with a self-sealing penetrable septum on the housing. Upon withdrawal of the needle from the septum this provides a fluid-tight sealing towards the interior of the housing. The septum and the needle further provides a fluid-tight sealing between the housing and the connector means when medication or therapeutic fluid is delivered to the patient from the external infusion system. Subcutaneous infusion devices of this generally known type are known from e.g. U.S. Pat. No. 5,522,803 to Teissen-Simony and U.S. Pat. No. 5,545,143 to Fischell.

The use of a medical puncturing device comprising a rigid needle may lead to some disadvantages during use of such device, viz. the potential danger of unintended exposure to the needle tip after the needle has-been discarded.

A medical puncturing device of a type providing some remedy for these disadvantages is disclosed in U.S. Pat. No. 5,533,974. This previously known device comprises a rigid needle and a protector housing wherein a biasing element, a cam and a gripping element are provided in order to lock the protector housing in relation to the needle at the pointed tip of this.

A further device is disclosed in U.S. Pat. No. 5,279,591. This previously known device comprises a rigid needle and a protector housing wherein a resilient spring means is provided to block the needle tip upon sliding the protector housing to the needle tip.

A still further device is disclosed in WO 9305840. This previously known device comprises a rigid needle and a protector housing wherein a resilient guard element is provided to block the pointed needle tip upon sliding the protector housing to the needle tip. Means for limiting the sliding movement are provided hereby ensuring the position of the protector housing.

Although these previously known medical puncturing devices to some extent give a satisfactory result with respect to the prevention of unintended and harmful needle sticks they all have a complicated construction requiring a cumbersome assembling process.

For this reason there is a need for improvements in the field of medical puncturing devices, the improvements relating to providing a medical puncturing device having satisfactory properties particularly with respect to providing a medical puncturing device which can be dismantled and discarded without the risk of causing any injuries, and at the same time being of a simpler construction requiring less effort in the manufacturing process.

The infusion needle according to the invention remedies the above mentioned disadvantages and provides further advantages which will become apparent from the following description.

SUMMARY OF THE INVENTION

In order to provide remedy for the above mentioned disadvantages a medical puncturing device has been developed, said medical puncturing device comprising a rigid needle being at one end adapted for facilitating the puncturing and comprising at the opposite end a hub, the hub comprising a handle part and a shield part being pivotable in relation to the handle part and further comprising locking means on the shield part and the handle part, the locking means being adapted to interlock the shield and the handle part in a pivoted position of the shield part where the rigid needle is covered by this.

By these features a simple construction is obtained which provides a reliable function as to preventing the risk of causing any injuries upon dismantling and discarding of the device.

In a preferred embodiment the shield part comprises a recess for accommodating the rigid needle. This can conveniently be obtained by configuring the shield part with an essentially U-shaped cross section.

The locking means on the handle part preferably comprises two arms having on their opposed sides barbs adapted to interlock with the corresponding locking means of the shield part. The locking means on the shield part preferably comprises two side flanges adapted to interlock with the corresponding locking means of the handle part. The flanges or the barbs are preferably tapered to facilitate the insertion of these into the corresponding locking means of the handle part and the shield part, respectively.

In order to facilitate the handling, the shield part preferably comprises an operating handle.

The hub is conveniently configured as a single part where the transition area between the handle part and the shield part is an area with a reduced rigidity, e.g. an area with a reduced material thickness. The medical puncturing device according to the invention is preferably manufactured from a plastics material, e.g. by a moulding process.

In a convenient embodiment the hub is prior to pivoting of the shield part adapted to grip around a body, e.g. an infusion device where a soft cannula belonging to this is to be inserted into a human body.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a medical puncturing device;

FIG. 2 is a side view of the medical puncturing device shown in FIG. 1;

FIG. 3 is a rear end view of the medical puncturing device shown in FIG. 2;

FIG. 4 is a front end view of the medical puncturing device shown in FIG. 2;

FIG. 5 is a bottom view of the medical puncturing device shown in FIG. 1;

FIG. 6 is a top view of the medical puncturing device shown in FIG. 1;

FIG. 7 is a sectional view after the line 7-7 in FIG. 5;

FIG. 8 is a perspective view showing the medical puncturing device where the shield part is pivoted to a locked position;

FIG. 9 is a side view showing the shield part pivoted to a locked position;

FIG. 10 is a perspective view where the medical puncturing device is mounted on an infusion device, and

FIG. 11 is a sectional view after the line 11-11 in FIG. 10.

DESCRIPTION OF THE PREFERRED EMBODIMENT

From FIG. 1 a preferred embodiment of the medical puncturing device appears. The device comprises a rigid needle 1 mounted in a needle hub 2. The needle is at the end opposite the needle hub 2 pointed or tapered so as to facilitate puncturing e.g. by the insertion of a soft cannula. The needle hub comprises a handle part 3, which is at one side connected to a shield part 4 via a hinge 5 formed as a material area with a reduced thickness. The shield part 4 has the shape of a half tube 6 having at the edges at both sides flanges 7,8. The shield part 4 comprises a pivoting handle 17. At the opposite side of the needle hub 2 in relation to the needle connection point the needle hub 2 comprises two arms 9,10 having barbs 11,12 at their opposed sides 15,16.

From FIG. 2 the puncturing device appears in a side view more clearly showing the transition area 5 where the shield part 4 is pivoted in relation to the handle part 3 by a pivoting action on the pivoting handle 17 by one hand while holding the handle part 3 with the other hand.

From FIG. 3 and FIG. 4 which are rear and front end views, respectively, the locking elements on the shield part and the handle part appear more clearly. Upon pivoting of the shield part in relation to the handle part these locking elements are caused to interact.

FIG. 5 and FIG. 6, which are bottom and top views, respectively, illustrate the locking elements in further detail.

From FIG. 7 the fastening site 14 for the rigid needle in the hub becomes apparent. The rigid needle is preferably secured in the correct position by a press fit connection or by gluing or welding.

From FIG. 8 and FIG. 9 it appears that the barbs 11,12 are co-operating with the flanges 7,8 of the shield part in order to interlock the shield part in the pivoted position. The deformed material in the transition area 5 together with the bend needle provide a biasing effect between the flanges 7,8 and the barbs 11,12. The needle hereby closely abuts on the side of the half tube 6 ensuring that unintended contact with the needle is avoided. This becomes especially clear in FIG. 9 where a part of the hub is cut away.

From FIG. 10 and FIG. 11 a field of use for the puncturing device appears. The puncturing device is inserted into an infusion device 18 for subcutaneous delivery of medication to a patient. This infusion device comprises a housing 19 in which a cavity 20 is provided and where a bore 21 leads medication from a pump or the like via a connector 25 to the cavity 20 where a soft cannula 22 is provided in fluid contact with the cavity 20 and where a further bore 23 covered with a self-sealing septum 24 is provided opposite the soft cannula 22. The puncturing device is inserted through the self-sealing septum 24, the cavity 20 and the soft cannula 22 and extends beyond the outer tip of the soft cannula. The puncturing device is held in place in relation to the connector 25 by means of barbs 26,27 on the shield part. When pressing the handle part 3 againts the pivoting handle 17 the barbs will release from their gripping position on the downward facing side of the connector 25 and the puncturing device may be retracted from the infusion set. The soft cannula is placed in an operational position, i.e. in a subcutaneous infusion site, by penetrating the skin and tissue of the patient by means of the puncturing device and afterwards retracting the puncturing device through the soft cannula, the cavity and the self-sealing septum. The puncturing device is not intended for further use and should therefore be folded and brought into a locked position as shown in FIG. 8 and FIG. 9 prior to discarding hereby ensuring that unintended harmful injuries caused by an exposed needle are avoided. 

1-10. (canceled)
 11. An infusion device comprising: a housing; a soft cannula extending from the housing, said soft cannula having an outer tip; a puncturing device adapted to be connected to said housing, said puncturing device comprising a rigid needle being adapted to extend through the cannula and beyond the outer tip thereof when the puncturing device is connected to said housing, said rigid needle being at one end adapted for facilitating puncturing and including at the opposite end a hub; said hub having a hinge, a handle part and a single shield part with a first end and a second free end, said first end of the shield part being pivotably connected to the handle part by means of said hinge, whereby said second free end is pivotable with respect to said hinge; said shield part being adapted to cover the rigid needle when pivoted with respect to said hinge, the second free end of the shield part extending beyond said one end of the rigid needle; and said hub further having a locking mechanism on the shield part and the handle part, the locking mechanism being adapted to interlock the shield and the handle part in a pivoted position of the shield part when the puncturing device is disconnected from the housing and the shield part is pivoted to cover at least a portion of the rigid needle.
 12. The infusion device as claimed in claim 11, wherein the shield part comprises a recess for accommodating the rigid needle.
 13. The infusion device as claimed in claim 11, wherein the shield part has an essentially U-shaped cross section.
 14. The infusion device as claimed in claim 11, wherein the locking mechanism on the handle part comprises two arms having on their opposed sides barbs adapted to interlock with the corresponding locking mechanism of the shield part.
 15. The infusion device as claimed in claim 14, wherein the edges of the barbs are tapered so as to facilitate the insertion into the corresponding locking mechanism of the shield part.
 16. The infusion device as claimed in claim 15, wherein the hub is formed as a single part and where the hinge between the handle part and the shield part is an area with a reduced rigidity.
 17. The infusion device as claimed in claim 15, wherein the hub is made of a plastics material.
 18. The infusion device as claimed in claim 15, wherein gripping means are provided on the shield part and the handle part, said gripping means being adapted to lock the hub to the housing.
 19. The infusion device as claimed in claim 11, wherein the locking mechanism on the shield part comprises two side flanges adapted to interlock with the corresponding locking mechanism of the handle part.
 20. The infusion device as claimed in claim 19, wherein the edges of the flanges are tapered so as to facilitate the insertion into the corresponding locking mechanism of the handle part.
 21. The infusion device as claimed in claim 11, wherein the shield part comprises an operating handle, the operating handle thereby being pivotable with respect to the handle part of the hub.
 22. The infusion device as claimed in claim 11, wherein the hub is formed as a single part and where the hinge between the handle part and the shield part is an area with a reduced rigidity.
 23. The infusion device as claimed in claim 11, wherein the hub is made of a plastics material.
 24. The infusion device as claimed in claim 11, wherein gripping means are provided on the shield part and the handle part, said gripping means being adapted to lock the hub to the housing.
 25. The infusion device as claimed in claim 11, wherein gripping means are provided on the shield part and the handle part, said gripping means being adapted to lock the hub to the housing, wherein the shield part comprises an operating handle, the operating handle being pivotable with respect to the handle part of the hub, and wherein pressing the handle part against the operating handle will release the gripping means and thereby the puncturing device from the housing.
 26. An infusion device comprising: a housing; a cannula extending from said housing; a hub adapted to be removably connected to said housing, said hub and said housing connected at least partially by a pair of projecting arms, each arm having a barb portion, said arms extending from said hub; a needle having a first end mounted in said hub, said needle adapted to extend through said cannula, and a shield hingedly connected to said hub, wherein said shield is pivotable to cover at least a portion of said needle when said hub is removed from said housing.
 27. The infusion device of claim 26 wherein said shield bends said needle when said shield is pivoted to cover at least a portion of said needle.
 28. The infusion device of claim 26 wherein said housing further comprises a medication bore within the housing for leading medication to said cannula.
 29. The infusion device of claim 26 wherein said housing further comprises a cavity formed within said housing and connected to said cannula.
 30. The infusion device of claim 26 wherein said hub and said shield are integrally molded together.
 31. The infusion device of claim 26 wherein said hub is substantially rectangularly shaped.
 32. The infusion device of claim 26 wherein said shield has a substantially U-shaped cross section.
 33. An infusion device comprising: a hub comprising: a handle having a needle mounted thereto and a pair of retaining arms extending from said handle; an elongated shield extending from said handle and rotatable relative to said handle; and an infusion housing releasably engaged by said arms, said housing having a cannula extending therefrom, wherein at least a portion of said needle extends through said housing and said cannula.
 34. The infusion device of claim 33 wherein said shield is hingedly connected to said handle.
 35. The infusion device of claim 33 wherein said shield is rotatable to cover at least a portion of said needle.
 36. The infusion device of claim 33 wherein said handle and said shield are integrally molded together.
 37. The infusion device of claim 33 wherein said shield further comprises a pair of flanges along at least a portion of said shield, said flanges being adapted to engage said arms when said shield covers at least a portion of said needle.
 38. The infusion device of claim 33 wherein said handle is substantially rectangularly shaped.
 39. The infusion device of claim 33 wherein said shield has a substantially U-shaped cross section.
 40. The infusion device of claim 33 wherein said hub is formed from a plastics material.
 41. The infusion device of claim 33 wherein said infusion housing further comprises a cavity.
 42. The infusion device of claim 33 wherein said handle is configured to be retained within an inserter device.
 43. An infusion device comprising: a housing; a cannula extending from said housing for delivery of medication through said cannula; and a hub removably connected to said housing, said hub comprising: a needle having a first end extending at least partially through said cannula when said hub is connected to said housing; a handle fixedly attached to an opposing end of said needle; and a shield hingedly connected to said handle, and adapted to cover at least a portion of said needle after said hub is removed from said housing.
 44. The infusion device of claim 43 wherein said handle is configured to be retained within an inserter device.
 45. The infusion device of claim 43 wherein said handle is substantially rectangularly shaped.
 46. The infusion device of claim 43 wherein said shield engages said handle when said shield is positioned to cover at least a portion of said needle.
 47. The infusion device of claim 43 further comprising retaining means extending from said handle.
 48. The infusion device of claim 47 wherein said retaining means are a pair of opposing legs.
 49. The infusion device of claim 47 wherein said retaining means is configured to retain said hub against said housing.
 50. The infusion device of claim 47 wherein said hub is adapted for placement and engagement with said housing down a center line of said housing.
 51. The infusion device of claim 43 wherein said shield has a substantially U-shaped cross section.
 52. The infusion device of claim 43 wherein said hub is formed from a plastics material.
 53. The infusion device of claim 43 wherein said shield bends said needle when said shield at least partially covers said needle.
 54. The infusion device of claim 43 wherein said infusion housing further comprises a cavity.
 55. The infusion device of claim 43 wherein said housing further comprises a medication bore within the housing for leading medication to said cannula.
 56. A medical puncturing device comprising: a hub having a pair of retaining members for removable attachment of said hub to an infusion device; a shield portion extending rearwardly from said retaining members of said hub in a first position; and a needle extending from said hub, wherein said needle is adapted to extend though a cannula of said infusion device; wherein said shield may be pivoted into a position where at least a portion of said needle is covered.
 57. The medical puncturing device of claim 56 wherein said shield is locked with said hub when said shield is covering at least a portion of said needle.
 58. The medical puncturing device of claim 56 further comprising a handle portion upstanding from said first portion.
 59. The medical puncturing device of claim 58 wherein said handle portion is substantially rectangularly shaped.
 60. The medical puncturing device of claim 58 wherein said handle portion is configured to be retained within an inserter device.
 61. The medical puncturing device of claim 56 wherein said shield has a substantially U-shaped cross section.
 62. The medical puncturing device of claim 56 wherein said pair of retaining members is configured to retain said hub against said infusion device.
 63. The medical puncturing device of claim 56 wherein said shield bends said needle when said shield is pivoted to said position wherein at least a portion of said needle is covered.
 64. A medical puncturing device comprising: a handle defining a needle retaining portion, said needle retaining portion being substantially rectangular in cross section and having a needle extending therefrom, said needle having a second end for puncturing the skin of a patient; a shield flexibly connected to said handle, a portion of said shield extending rearwardly from said handle in a first position and away from said needle, said portion being substantially U-shaped in cross section; and a pair of protrusions extending from said shield, said protrusions adapted for retention of said shield with said handle when said shield is in a position covering at least a portion of said needle.
 65. The medical puncturing device of claim 64 wherein said handle portion is configured to be retained within an inserter device.
 66. The medical puncturing device of claim 64 wherein said shield has a substantially U-shaped cross section.
 67. The medical puncturing device of claim 64 wherein said shield extends substantially perpendicularly to said needle in said first position.
 68. The medical puncturing device of claim 64 wherein said shield bends said needle when said shield is pivoted into a position covering at least a portion of said needle.
 69. The medical puncturing device of claim 64 wherein said protrusions are elongated an extend along at least a portion of said length of said shield.
 70. A medical puncturing device comprising: a substantially rectangularly shaped handle having a pair of retaining arms extending therefrom, said arms being adapted to removably connect said device to an infusion set; a needle having a first end mounted in said handle and a second end extending downward from said handle; and a shield pivotally connected to said handle, said shield having a portion extending substantially rearwardly in a first position to allow connection of said device to an infusion set; wherein said shield pivots with respect to said handle wherein said shield covers at least a portion of said needle.
 71. The medical puncturing device of claim 70 wherein said handle is substantially rectangularly shaped.
 72. The medical puncturing device of claim 70 wherein said handle is adapted so a user can grasp said handle together with said infusion set.
 73. The medical puncturing device of claim 70 wherein said handle is configured to be retained within an inserter device.
 74. The medical puncturing device of claim 70 wherein said shield has a substantially U-shaped cross section.
 75. The medical puncturing device of claim 70 wherein said pair of retaining arms is configured to retain said device against said infusion set.
 76. The medical puncturing device of claim 70 wherein said shield bends said needle when said shield is pivoted into a position covering at least a portion of said needle.
 77. A medical puncturing device comprising: a handle defining a needle retaining portion; a needle fixedly attached to said needle retaining portion and configured for insertion through an infusion housing; a shield hingedly connected to said handle, a portion of said shield extending rearwardly from said handle in an unlocked position; and a pair of gripping arms positioned on one of said shield and said handle for removable connection of said device to said infusion housing; wherein said shield is adapted to engage said gripping arms and cover at least a portion of said needle.
 78. The medical puncturing device of claim 77 wherein said handle is substantially rectangularly shaped.
 79. The medical puncturing device of claim 77 wherein said handle is configured to be retained within an inserter device.
 80. The medical puncturing device of claim 77 wherein said handle tapers inwardly from a base of said handle toward a distal end thereof.
 81. The medical puncturing device of claim 77 wherein said handle includes an generally cylindrical inner wall structure integrated within a substantially rectangularly-shaped outer wall structure.
 82. The medical puncturing device of claim 77 wherein said shield has a substantially U-shaped cross section.
 83. The medical puncturing device of claim 77 wherein said pair of gripping arms is configured to retain said device against said infusion housing.
 84. The medical puncturing device of claim 77 wherein said pair of gripping arms is mounted on said handle.
 85. The medical puncturing device of claim 77 wherein said shield may be pivoted to cover at least a portion of said needle.
 86. The medical puncturing device of claim 85 wherein said shield bends said needle when said shield is pivoted to cover said needle.
 87. The medical puncturing device of claim 77 wherein said handle and said shield are integrally molded together. 